Europe

EMA publishes adaptive pathways report

Tuesday, August 9, 2016

The EMA has published a final report on the experience gained during its pilot project on adaptive pathways, a product development concept for medicines that address patients’ unmet medical needs.

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EMA updates organizational structure

Tuesday, August 2, 2016

The EMA has announced organizational adjustments and important strategic amendments of its corporate management structure that will result in a leaner, more streamlined architecture and improved administrative support. Building on the 2013/2014 reorganization of the agency, the changes fine-tune the re-engineered organizational model to further improve efficiency and effectiveness of EMA’s operations. All changes will come into effect on September 1, 2016.

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EMA suspends Semler’s medicines over flawed studies

Monday, July 25, 2016

The EMA has recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted at Semler Research Centre Private Ltd, Bangalore, India. The Agency has also recommended that medicines currently being evaluated for authorization and which rely only on bioequivalence studies from this site should not be authorized until bioequivalence is demonstrated using alternative data. Bioequivalence studies usually form the basis for approval of generic medicines.

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EMA to revise guidance on first-in-human clinical trials after Bial trial deaths

Monday, July 25, 2016

The EMA, in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to current guidance on first-in-human clinical trials to further improve strategies to identify and mitigate risks to trial participants. These changes are outlined in a new concept paper which has been released for public consultation. Comments on the proposals should be sent to FIH-rev@ema.europa.eu until September 30 using the form provided.

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Richter acquires Finox Holding for $185.2M

Friday, July 1, 2016

Gedeon Richter has announced the acquisition of Finox Holding, a privately held Swiss biotech company focused on development and commercialization of innovative and cost effective products addressing female fertility. Gedeon Richter, headquartered in Budapest/Hungary, is a major pharmaceutical company in Central Eastern Europe, with an expanding direct presence in Western Europe. 

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EMA, FDA reinforce collaboration on patient engagement

Tuesday, June 28, 2016

The EMA and the FDA have set up a new ‘cluster’ on patient engagement. The cluster will provide a forum to share experiences and best practices on the way the two agencies involve patients in development, evaluation and post-authorization activities related to medicines.

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Ombudsman calls for more transparency

Tuesday, June 14, 2016

The European Ombudsman, Emily O’Reilly, has welcomed increased transparency in the clinical testing of Humira, one of the world’s biggest selling drugs, following her inquiry into the publication of clinical study reports.

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